BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3952331 · Received July 17, 2014

    Report

    Report Number
    2951250-2014-00231
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE PART OF IMPLANT REMAINED IN FALLOPIAN TUBE AT THE TIME OF IMPLANT RELEASE (COMPLICATION OF DEVICE INERTION). REPORTER CAUSALITY ASSESSMENT WAS NOT PROVIDED. THE ABOVE MENTIONED EVENTS WERE CONSIDERED NON-SERIOUS. PART OF IMPLANT REMAINED IN FALLOPIAN TUBE AT THE TIME OF IMPLANT RELEASE, INTERPRETED AS A DEVICE BREAKAGE, IS UNLISTED ACCORDING TO THE REFERENCE SAFETY INFO FOR ESSURE AND WAS REGARDED AS A NEAR-INCIDENT, AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. THE REMAINING EVENT IS LISTED AND NON-INCIDENT. SINGLE CASES OF ESSURE BREAKAGE HAVE BEEN REPORTED. IN THIS PARTICULAR CASE, CONSIDERING THAT THE EVENTS OCCURRED DURING ESSURE PLACEMENT PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE THERAPY CANNOT BE EXCLUDED. F/U INFO AND PRODUCT TECHNICAL ANALYSIS ARE BEING SOUGHT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT REC'D FROM A PHARMACIST ON (B)(6) 2014 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PART OF IMPLANT REMAINED IN FALLOPIAN TUBE AT THE TIME OF IMPLANT RELEASE (COMPLICATION OF DEVICE INSERTION). NO INFO WAS GIVEN ON THE PATIENT'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATION. ON (B)(6) 2014 THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. AT THE TIME OF IMPLANT RELEASE, A PART REMAINED IN THE FALLOPIAN TUBE. THE REPORTER'S CAUSALITY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420045 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C13145
    420046 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C13145

    Patients

    Seq Age Sex Outcome Treatment
    1 Female